Contractor

Job Title: GXP CSV Validation Consultant

Responsibilities

• Validation Lifecycle Management: Author and review key Computer System Validation (CSV) deliverables including Validation Master Plan, GxP Assessment & Risk/Impact Assessment, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Installation Qualification (IQ), Operational Qualification (OQ) test scripts, and Validation Summary Reports
• Risk Assessment: Identify risks and develop test strategies for change management projects
• Test Execution: Execute test scripts, manage defects, and prepare traceability matrices
• Compliance Assurance: Ensure compliance with regulatory guidelines such as 21 CFR Part 11, 21 CFR 210, and 21 CFR 211
• Documentation: Maintain and review validation documentation, ensuring completeness and accuracy
• Stakeholder Collaboration: Work effectively within a team and independently, collaborating with business users, IT, and QA teams
  

Required Skills

• Experience: Minimum of 10 years in Computer System Validation (CSV) activities in GxP related applications
• Technical Knowledge: Proficiency in GAMP, GxP risk assessments, change management, and validation testing
• Tools: Experience with tools like ALM, DMS, JIRA etc.
• Methodologies: Adept with Agile and Waterfall methodologies for software development and validation
• Regulatory Compliance: Strong understanding of regulatory guidelines for GxP validation
• Communication: Excellent communication skills, leadership qualities, and ability to work under time and resource constraints
  

Preferred Skills

• Domain Knowledge: Extensive knowledge of Life Sciences/Pharma domain
• Project Management: Competent in conflict management, escalation handling, and direct client interaction
  

Qualifications

• Education: Bachelor's degree in Computer Science, Information Technology, or related field.
• Certifications: Relevant certifications in CSV, GxP compliance, or related areas are a plus.